| CTRI Number |
CTRI/2025/01/079590 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Single Period Parallel Truncated Oral Bioequivalence Design In Adult Patient With Mild And Moderate Iron Deficiency Anemia Under Fed Conditions study comparing Iron III Hydroxide Polymaltose 100 mg Tablet |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Single Period Parallel Truncated Oral Bioequivalence Study Comparing Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International With Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd In Adult Patient With Mild And Moderate Iron Deficiency Anemia Under Fed Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0096-24-IRON Version 01 Dated 21 Nov 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna
Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna
Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna
Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Assist Pro
Suite 3 03 4 Columbia Court
Norwest NSW 2153 Australia
|
|
|
Primary Sponsor
|
| Name |
Assist Pro |
| Address |
Suite 3 03 4 Columbia Court Norwest NSW 2153 Australia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu
Thudiyalur Coimbatore 641029 Tamil Nadu India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Life science and Research private limited |
Clinical Pharmacology
unit Ground Floor Door
No 29 A Krishna
Maduravanam
Vellakinar pirivu
Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee Registration No ECR/84/Indt/TN/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D599||Acquired hemolytic anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Iron III Hydroxide Polymaltose 100 mg Tablet |
Single Oral Dose of Iron III Hydroxide Polymaltose 100 mg Tablet Will Be administered
in study Period Total Duration is 05 Days |
| Comparator Agent |
Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet |
Single Oral Dose of Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Will Be administered in study Period Total Duration is 05 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with iron deficiency anemia of age between 18 to 45 years and Body Mass Index BMI ranges between 18 50 kg m2 to 30 00 kg m2 according to the formula of BMI weight kg height m2
Diagnosed iron deficiency anemia based on two criteria
a hemoglobin level below 110 g L in men and women but above 80 g L Mild Hemoglobin 10 0 g dL to lower limit of normal Moderate Hemoglobin 8 0 to 10 0 g dL
b serum ferritin levels below 30 µg L
Patients who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in
Patients whose screening laboratory values are within normal limits or considered by the physician or principal clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments
Willing to consume Ovo lacto vegetarian diet and Standard breakfast Dosing day
Willing to comply with all requirements of this study protocol as well as instructions from the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination for female Patients
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check in
If the Patients is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the Patient s last study related visit for eligible Patients only if applicable has a negative serum pregnancy test and is of non childbearing potential defined as 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
intrauterine device IUD with a low failure rate of 1 per year
or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the Patient becomes sexually active
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Iron III Hydroxide Polymaltose 100mg Tablet or its inactive ingredients
Administration of any iron containing drugs during the last 3 months
History of erythropoietin drugs administration
Patients with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus pre existing gallbladder disease and Heme metabolism disorders eg sideroachrestic anaemia lead anaemia thalassaemia
Other types of anemia apart from iron deficiency will be excluded from enrollment in the study
Malignant diseases including blood and lymphoid tissue disorders leukemia Hodgkin disease myelodysplastic syndrome myeloma etc at screening or in the past medical history provided that the remission was less than 5 years before screening
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Blood loss leading to hemodynamic instability
The necessity of parenteral iron therapy ie the following cases
a impaired absorption in case of an intestinal pathology
enteritis coeliac disease malabsorption small intestinal resection stomach resection including the duodenum
b exacerbation of gastric or duodenal ulcer
c the necessity of quick iron saturation eg in patients with iron deficiency anaemia with upcoming surgery
d continuous vast blood loss and other causes at the discretion of the investigator
Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48 00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48 00 hours prior to clinic admission and throughout the entire study
Patients who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study
Patients who have taken any unusual diet for whatever reason eg low salt for 48 00 hours prior to dosing and throughout the study
Patient who had participated in any other study within the 90 days of check in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in
Positive results for alcohol test prior to check in
Any blood donation excess blood loss within 90 days of check in
Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in
Use of hormone replacement therapy for a period of 06 months prior to dosing
Female Patients demonstrating a positive pregnancy screen
Female Patients who are currently lactating
Females are likely to become pregnant during the course of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International with Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd |
23 Time points
minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 01 50 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs 72 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International with Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd |
23 Time points
minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 01 50 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs 72 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2025 |
| Date of Study Completion (India) |
01/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open-Label, Balanced, Randomized,
Single-Dose, Two-Treatment, Two-Sequence, Single-Period, Parallel, Truncated, Oral
Bioequivalence Design In Adult, Patient With Mild And Moderate Iron Deficiency
Anemia, Under Fed Conditions
At least 36 number of healthy adult human subjects will be recruited to evaluate the Bioequivalence of Test product with the Reference product
As per the discretion of the Investigator a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 36 subjects in period I alone
If needed the study
will be conducted as batch wise
In each period subjects will be housed in the clinical facility for at least 11 00 hrs pre dose to 72 00 hrs post dose
After an overnight fasting of at least 08 00 hours, in the morning a single oral dose of either the test product T or reference product R will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre dose 00 00 hr within 75 minutes of before dosing and at 03 00 06 00 12 00 24 00 36 00 and 48 00 plus or minus 60 minutes post dose Physical examination and vitals will be recorded before check in check out 72 00 hours for each period and at any time if necessary
Monitoring for adverse events will be done throughout the study period in clinical phase |